- Email: [email protected]
Single Center Prospective Randomized Trial of Laparoscopic Nissen Versus Anterior 90° Fundoplication
Single Center Prospective Randomized Trial of Laparoscopic Nissen Versus Anterior 90 Fundoplication Gary M. Spence, M.D., F.R.C.S., David I. Watson, M.D., F.R.C.S., Glyn G. Jamiesion, M.S., F.R.C.S., F.R.A.C.S., Carolyn J. Lally, R.N., R.M., Peter G. Devitt, M.S., F.R.C.S., F.R.A.C.S.
Although Nissen fundoplication is a very effective treatment for gastroesophageal reflux, it is associated with a small incidence of troublesome postoperative side effects. To prevent this, progressive modification of surgical techniques has led to the development of an anterior 90 fundoplication. We undertook a prospective randomized trial to compare this procedure with Nissen fundoplication to determine whether it would achieve a better clinical outcome. Patients presenting to a single center for primary laparoscopic antireflux surgery were randomized to undergo either an anterior 90 fundoplication (n 5 40) or a Nissen fundoplication without division of the short gastric vessels (n 5 39). Clinical questionnaires were used to assess outcome at 1 month, 3–6 months, and 12 months. Both patients and the clinical interviewer were masked as to which procedure was performed. Follow-up with endoscopy, esophageal manometry, and pH monitoring was also undertaken. Operating time was similar for the two procedures (60 minutes for anterior vs. 55 minutes for Nissen fundoplication). Early postoperative complications were more common after Nissen fundoplication (18% vs. 5%). Two patients underwent laparoscopic reoperation for recurrent reflux after anterior 90 fundoplication, and four underwent laparoscopic reoperation after Nissen fundoplication (dysphagia, 3 patients; acute hiatus hernia, 1 patient). One year after surgery, dysphagia and other wind-related side effects were less common after anterior 90 fundoplication. Control of reflux symptoms and satisfaction with the overall outcome was similar for the two procedures. Anterior 90 fundoplication is followed by fewer side effects than Nissen fundoplication. This advantage is offset by a greater likelihood of reflux recurrence. However, this does not diminish patient satisfaction. ( J GASTROINTEST SURG 2006;10:698–705) Ó 2006 The Society for Surgery of the Alimentary Tract KEY WORDS: Anterior partial fundoplication, dysphagia, gastroesophageal reflux, laparoscopy, Nissen fundoplication
Laparoscopic fundoplication has become the operative modality of choice for the surgical treatment of moderate to severe gastroesophageal reflux.1 The majority of laparoscopic fundoplications currently constructed are 360 fundal wraps, similar to the procedure originally described by Nissen. Despite achieving excellent control of reflux in the majority of patients, however, the 360 fundoplication can be followed by troublesome postoperative side effects. These include dysphagia and wind-related problems such as abdominal bloating, inability to belch, and flatulence.2
To overcome this, Nissen’s operation has been progressively modified. Undertaking a laparoscopic anterior partial fundoplication instead of a Nissen procedure has the potential to give good reflux control, but with less side effects. In 1999, we reported the early results of the first prospective randomized trial that compared the outcome of a Nissen fundoplication with an anterior 180 partial fundoplication.3 This study demonstrated that both procedures achieved satisfactory early control of reflux, but with less side effects after anterior 180 fundoplication. Longer term follow-up has since
From the University of Adelaide Department of Surgery, Royal Adelaide Hospital (G.M.S., G.G.J., C.J.L., P.G.D.), Adelaide, South Australia; and Flinders University Department of Surgery, Flinders Medical Centre (D.I.W.), Bedford Park, South Australia, Australia. Financial support for this study was provided from a project grant (no. 157986) from the National Heath and Medical Research Council of Australia (to D.I.W. and G.G.J.). Reprint requests: David I. Watson, M.D., F.R.C.S., Head, Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia. e-mail: [email protected] Ó 2006 The Society for Surgery of the Alimentary Tract
698 Published by Elsevier Inc.
1091-255X/06/$dsee front matter doi:10.1016/j.gassur.2005.10.003
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confirmed the durability of the anterior 180 fundoplication procedure beyond 5 years.4 Although side effects are less likely after anterior 180 fundoplication compared with Nissen fundoplication, a small risk of persistent dysphagia and wind-related problems remains. This led us to further refine the anterior fundoplication technique, resulting in the development of an anterior 90 fundoplication. Experimental and initial clinical studies have confirmed that anterior 90 fundoplication achieves good short-term reflux control, with a low risk of side effects.5,6 In addition, a multicenter prospective doubleblind randomized trial of laparoscopic Nissen fundoplication versus anterior 90 fundoplication has recently been published.7 This study was coordinated by our unit, and we contributed patients to it. The trial demonstrated that overall satisfaction with surgery was better 6 months after anterior 90 fundoplication, although this was offset to some extent by better reflux control in patients who underwent a Nissen fundoplication.7 In this recently reported study, the laparoscopic Nissen fundoplication procedures included division of the short gastric blood vessels. Four other randomized trials, including one from our unit, have shown that dividing these vessels is unnecessary during Nissen fundoplication,8–13 and two of these trials have demonstrated an association between division of the vessels and wind-related side effects.8,10 For this reason, we initiated another randomized trial of laparoscopic anterior 90 versus Nissen fundoplication, in which the short gastric vessels were not divided during Nissen fundoplication. This new trial is a single center experience with a different cohort of patients, rather than the combined experience of a larger group of surgeons. PATIENTS AND METHODS The protocol used for this study was similar to that used in other reported randomized trials undertaken by the authors and reported elsewhere.3,9 Participant Assignment Patients undergoing laparoscopic fundoplication for gastroesophageal reflux were randomly assigned to undergo either a total 360 (Nissen) fundoplication without division of the short gastric blood vessels or an anterior 90 partial fundoplication. Informed consent was obtained from all participants, and randomization was undertaken in the operating theater by opening one of 100 previously sealed opaque envelopes after surgery commenced.
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Patient Selection and Preoperative Investigation All patients with reflux who presented for laparoscopic antireflux surgery were considered for enrollment. Patients were excluded if they had a severe esophageal motility disorder that precluded the performance of a Nissen fundoplication, if they required a contemporaneous abdominal procedure (e.g., cholecystectomy), or had previously undergone any type of gastric surgery. All patients underwent preoperative investigation with esophageal manometry and endoscopy. Twenty-four-hour pH monitoring was performed to confirm reflux in patients who did not have unequivocal reflux disease demonstrated by endoscopy.
Operative Technique and Postoperative Care Laparoscopic Nissen fundoplication was performed using a technique described previously.14 This comprised preservation of the hepatic branch of the vagus nerve, routine posterior hiatal repair, and the construction of a short, loose Nissen fundoplication around a 52 Fr intraesophageal bougie. The short gastric vessels were not divided in any patients. The technique for anterior 90 fundoplication has also been described previously.6 The initial steps are similar to those undertaken for the Nissen proceduredmobilization of the esophagus, preservation of the hepatic branch of the vagus nerve, and posterior hiatal repair. The anterior 90 fundoplication was fashioned by first placing an esophagopexy suture between the posterolateral aspect of the right side of the distal esophagus and the posterior aspect of either the right pillar or both pillars of the esophageal hiatus. Two sutures were next placed between the left side of the esophagus and the adjacent gastric fundus to accentuate the angle of His, and the gastric fundus was then sutured loosely over the left side of the front of the esophagus by using an apical suture that anchored the fundus to the anterior esophagus and the apex of the hiatus. Finally, the inferior edge of the fundal fold lying in front of the esophagus was sutured to the esophagogastric junction in the midline. The short gastric vessels were not divided, and an intraesophageal bougie was not used. Patients were allowed oral fluids postoperatively on return to the ward, and soft solid food was commenced on the first postoperative day. Patients were instructed to remain on a soft diet for the first 3–4 weeks after surgery and then to gradually increase the consistency of their food intake thereafter.
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Masking
Table 2. Outcome assessment
The type of fundoplication performed was concealed from the patients during follow-up. Followup was undertaken by a research assistant who was masked to the randomization of each patient. Final data analysis for this paper was performed in late 2004 by a surgeon investigator (G.M.S) who was not involved in the original surgery.
Excellent Good Fair
Clinical Follow-up Preoperative and postoperative data were collected using a standard form. Follow-up data at 1 month, 3–6 months, and 1 year after surgery were obtained by telephone interview. Longer-term follow-up will be obtained in due course. The presence or absence of the following symptoms was sought: heartburn, epigastric pain, regurgitation, dysphagia for solids, dysphagia for liquids, odynophagia, early satiety, epigastric bloating, anorexia, nausea, vomiting, wheezing, coughing, and increased flatulence. The ability to relieve bloating and whether a normal diet was being consumed were also determined. Heartburn was also scored using a visual analogue scale (0 5 no heartburn, 10 5 severe heartburn). Dysphagia was scored by several methods. Visual analogue scales (0 5 no dysphagia, 10 5 total dysphagia) were applied separately for solids and liquids; a previously validated score (0 5 no dysphagia, 45 5 severe dysphagia) that combines information about difficulty swallowing nine types of liquids and solids was used as well.9,15 Overall outcome was determined using three further scales and a question. Patients were asked to assess the outcome of surgery by using a modified Visick grading (Table 1) and were asked to score the outcome as excellent, good, fair, or poor (Table 2). An overall assessment of satisfaction with the operative outcome was also determined using a further visual analogue scale (0 5 dissatisfied, 10 5 satisfied). In addition, patients were asked whether they thought that their initial decision to have a laparoscopic fundoplication was correct or not. The occurrence of any Table 1. Modified Visick grading system 1 2
3 4 5
No symptoms Mild symptoms easily controlled by simple care such as avoiding certain foods or eating small meals, etc. Moderate symptoms not controlled by simple care but not interfering with social or economic life Moderate symptoms interfering with social or economic life Symptoms as bad worse than preoperatively
Poor
Complete recovery Major improvement with minor problems Major improvement with still significant problems or adverse effects Minor or no improvement or deterioration
complications and the need for further surgery, whether early (within 6 weeks of the initial surgery) or late, was also recorded. Objective Follow-up Three to six months after surgery, patients were invited to undergo esophageal manometry, 24hour-ambulatory pH monitoring, and endoscopy. These investigations sought to obtain an objective assessment of lower esophageal sphincter function, postsurgical anatomy, and the degree to which reflux was controlled. Statistical Analysis The primary clinical outcomes that the trial was designed to evaluate were postoperative dysphagia and control of reflux symptoms. It was determined that 80 patients (40 in each group) would be needed to demonstrate a 15% difference in these outcome measures at a statistical significance level of P ! 0.05 and power of 80%. All analyses and comparisons between the two groups were performed on an intention-to-treat basis. Data were entered onto a computerized database (Filemaker Pro version 7, Filemaker Corporation, Santa Clara, CA) and analyzed with SPSS version 10 for Windows (SPSS Inc, Chicago, IL). Data are expressed as mean (standard error of the mean; mean [SEM]) or median (interquartile range; median [IQR]). Categorical variables were compared by using the Fisher exact test. Continuous variables that followed a parametric distribution were compared by using the independent samples t test. Nonparametric data were compared using the Mann-Whitney U test. Statistical significance was accepted if P ! 0.05. The protocol for this trial was approved by the Human Research Ethics Committee of the Royal Adelaide Hospital. RESULTS Seventy-nine patients who underwent a laparoscopic fundoplication between February 1999 and August 2003 at the Royal Adelaide Hospital were
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Laparoscopic Nissen vs. Anterior 90 Fundoplication
entered into this trial. Thirty-nine patients were randomized to undergo a Nissen fundoplication and 40 patients an anterior 90 partial fundoplication. Follow-up data was available for 71 (90%) patients at the 1-month follow-up point, 72 (91%) patients at 3–6 months follow-up, and 64 (81%) at 1 year follow-up. Missing data were due to the inability to contact patients at these specific follow-up points. Of the 15 patients who were not contacted at 1year postsurgery, 14 had 3–6 month follow-up data available, and 10 of these 14 patients had a good or excellent outcome at the point of last review. Data was available for 78 (99%) patients in at least one of the last two follow-up points. Preoperative Assessment Both study groups were well matched for preoperative parameters (Tables 3 and 4). The degree of heartburn experienced by each group and scored on a visual analogue scale was also comparable between both groups (Table 5), as was dysphagia (Table 6). Likewise, preoperative esophageal manometric parameters and endoscopic findings were similar for the two groups. Operation Operations were carried out under the care of three surgeons. Thirty-one procedures (39%) were performed by a consultant, and 48 (61%) were performed by a trainee under supervision. The seniority of the first operator was different for the two groups, there being a higher representation of trainees as the primary surgeon in the Nissen fundoplication group (74% vs. 48%; P 5 0.02). There was no deliberate Table 3. Preoperative patient characteristics Type of fundoplication Variable
Age, y Sex, M/F Height, cm Weight, kg Previous upper abdominal surgery Duration of symptoms (y)
Anterior (n 5 40)
Nissen (n 5 39)
46 (2) 24/16 171 (3) 84 (3) 6 (15%)
47 (2) 19/20 169 (2) 86 (3) 6 (15%)
0.62* 0.37‡ 0.51* 0.59* 0.99†
7 [4–12]
6 [3–20]
0.81‡
P value
Data are given as mean (standard error of mean), or median [interquartile range]. *Student’s t test. † Fisher exact test. ‡ Mann-Whitney U test.
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bias for this parameter, as randomization was always undertaken after commencing surgery. One patient who was randomized to undergo a Nissen fundoplication underwent an anterior 90 fundoplication, when the surgeon could not bring the gastric fundus behind the esophagus. This was due to the combined difficulties of excessive adipose tissue in the region of the cardia and a thickened gastric wall. The operating surgeon thought that this problem would not be solved by dividing the short gastric vessels, and hence, a partial fundoplication was performed. All other patients had a fundoplication constructed according to the randomization schedule. Outcomes were analyzed on an intentionto-treat basis. The laparoscopic procedure was converted to open surgery for one patient in the anterior 90 fundoplication group. This was because of intra-abdominal adhesions. All other procedures were completed laparoscopically. Operating times were similar for the two groups (median 60 minutes; interquartile range 45–75 minutes for anterior 90 fundoplication vs. median 55 minutes; interquartile range 40–65 minutes for Nissen fundoplication; P 5 0.18). Operating surgeons were asked to rate the degree of difficulty of the operative procedure by using a scale from 1 to 10. There was no difference in difficulty rating between the two groups (4 [3–7] for anterior 90 fundoplication vs. 4 [3–7] for Nissen fundoplication; P 5 0.92). Early Hospital Outcome The time interval between surgery and the commencement of oral fluids as well as the duration of postoperative hospital stay were not influenced by the type of fundoplication. Time to commencement of solids was longer in the Nissen fundoplication group (Table 7). The incidence of postoperative complications was higher in the Nissen fundoplication group (18% vs. 5%; P 5 0.09). However, most complications were minor and did not surgically require intervention, or delay discharge from the hospital. After anterior 90 fundoplication, there was one episode of chest infection and one episode of intraoperative cervical subcutaneous emphysema. After Nissen fundoplication, one patient developed urinary retention, one patient developed an umbilical port-site hernia, one patient suffered from excessive retching in the early postoperative period, which settled spontaneously, and three patients developed an intraoperative pneumothorax (none of which required any specific intervention). In addition, one patient in the Nissen group was found to have an acute paraesophageal hernia on a routine barium
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Table 4. Assessment of symptoms Postoperative Preoperative Symptom
Heartburn Epigastric pain Regurgitation Odynophagia Early satiety Epigastric bloating Anorexia Nausea Vomiting Cough Wheeze Can relieve bloat Eats normal diet Increased flatus
1 month
3–6 months
1 year
Anterior %
Nissen %
Anterior %
Nissen %
Anterior %
Nissen %
Anterior %
Nissen %
100 56 79 15 35 50 9 29 35 35 24 55 70 NA
97 71 89 24 53 61 16 50 34 34 26 53 70 NA
11 49 11* 20 60 37 26 23 3 20 9 38 47 54
14 39 39* 33 61 47 31 19 17 25 11 56 27 44
22 36 15 18 49 55 9 27 9 21 3 50 89 46
3 33 26 15 59 56 10 26 8 13 13 61 74 67
16 29 3* 7 26* 32 3 7* 7 26 0 69 90 42*
12 46 27* 18 67* 39 12 30* 6 15 0 50 83 79*
*P ! 0.05 (Nissen vs. anterior fundoplication, Fisher exact test).
swallow X-ray carried out on the day after surgery. This was repaired laparoscopically on the second postoperative day, and the patient then made an uneventful recovery. Clinical Outcome at 1 Month to 1 Year After Operation A detailed analysis of the clinical outcome at 1 month, 3–6 months, and 1 year are summarized in Tables 4, 5, 6, and 8. At 1 and 3–6 months, there were significant differences between the two groups for the symptoms of regurgitation at 1 month (less after anterior 90 fundoplication) and heartburn at 3–6 months (less after Nissen fundoplication). At 1 year, there were significant differences in the incidence of regurgitation, early satiety, nausea, and flatulence (all less after anterior 90 fundoplication). There was no significant difference between the Table 5. Assessment of heartburn by visual analogue scale Types of fundoplication
Preoperative Postoperative 1 month 3–6 months 1 year
Anterior
Nissen
P value
7 [2.8–9.1]
5 [3–8]
0.31
0 [0–0] 0 [0–0.5] 0 [0–2]
0 [0–0] 0 [0–0] 0 [0–0]
0.99 0.01* 0.08
Data are expressed as median [interquartile range]. *P ! 0.05 (Nissen vs. anterior fundoplication, Mann Whitney U test).
two groups for the assessment of heartburn by the yes/no question at 1 year (Table 4). With regard to the assessment of heartburn by using the visual analogue scale, the findings were similar to the findings determined by the yes/no question. A statistically significant difference was found in the heartburn scores at 3–6 months (less after Nissen fundoplication), but this was not found at 1 year (Table 5). With regard to the clinical assessment of dysphagia, there were significant differences between the two study groups, with less dysphagia experienced after anterior 90 fundoplication (Table 6). At 1 year, the incidence of dysphagia for solid foods, the visual analogue scores for dysphagia (for both liquids and solids), and the 0–45 dysphagia score all concurred. The satisfaction score, outcome profile, and modified Visick grading all failed to reveal a statistically significant advantage for either type of the fundoplication (Table 8). In both groups, most patients were satisfied with the outcome of their surgery. At both 3–6 months and 1 year postprocedure, more patients in the anterior 90 fundoplication group expressed the view that they had made the correct decision to undergo surgery (86% vs. 77% at 3–6 months, 87% vs. 76% at 1 year). However, these differences were not statistically significant (Table 8). Postoperative Investigations Patient compliance with scheduled objective postoperative investigations was low. Twenty-five (32%) patients underwent postoperative upper gastrointestinal endoscopy, 23 (29%) underwent 24-hour-pH
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12 [3.5–19.5]* 18*
Table 7. Early hospital outcomes Types of fundoplication Variable
0 [0–8.7]* 56*
Postoperative stay (days) Days to taking oral fluids Days to taking solid foods
24 [17.7–29.9]* 11 16 [0–25.5]* 27
Nissen
P value
2 [2–3] 1 [1–1] 1.5 [1–2]*
2 [2–3] 1 [1–1] 2 [1.5–2]*
0.42 0.52 0.03
monitoring, and 25 (32%) underwent esophageal manometry. Upper gastrointestinal endoscopy revealed an intact fundoplication and satisfactory repair of hiatus hernia in all patients studied. With regards to Savary-Miller grading of esophagitis, one of eight patients was scored as Savary-Miller grade 1 after anterior 90 fundoplication, and 1 of 16 patients had grade 3 esophagitis after Nissen fundoplication. Esophagitis was not present in any other patient. Twenty-four-hour pH monitoring demonstrated normalization of acid exposure times in all but one of the 23 patients studied. This patient had undergone a Nissen fundoplication. The percentage time with pH less than 4 over the 24-hour study period was significantly less in the Nissen fundoplication group (0% [0%–0.6%] vs. 0.7% [0.3%–2.5%]; P 5 0.02). The postoperative lower esophageal sphincter resting pressure measured at esophageal manometry was similar for the two groups (anterior 14 mmHg [10–24] vs.
9.5 [0–23.5]* 33*
5 [3.3–7.8]* 0 [0–4.3] 3 [0–6.8]* 0 [0–0]*
Anterior
Data expressed as median [interquartile range]. *P ! 0.05.
0 [0–12]* 66*
2 [0–6]* 0 [0–3]* 0 [0–2]* 0 [0–0]* 2.5 [0–6.3]* 0 [0–1]
13* 0 49 21* 30 0* 69 14 63 3
0 [0–2.5]* 0 [0–0]
49* 3
Nissen Nissen Anterior
Anterior
Nissen
Anterior
1 year 3–6 months 1 month
Postoperative
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Table 8. Postoperative Visick grading, outcome grading, and satisfaction scores
3–6 months *P ! 0.05. † Data are expressed as % or median [interquartile range].
8.2 [0–15.9] 44 1.7 [0–19.5] 50
0 [0–5] 0 [0–2.5] 0 [0–3.3] 0 [0–0]
21 8 32 6
Dysphagia for: Solids, % Liquids, % Visual Analogue Scale Solids Liquids Dysphagia score Overall result† Scored 0 only, %
Nissen Anterior Symptom
Preoperative
Table 6. Assessment of dysphagia
Postoperative status
Variable
1 year
Anterior Nissen Anterior Nissen
Modified Visick grade a 1 25% 21% 2 47% 54% 3 6% 3% 4 8% 18% 5 14% 5% Outcome Excellent 43% 28% Good 30% 41% Fair 11% 23% Poor 16% 8% Satisfaction 9 [7.5–10]9 [7–10]9 score* ‘‘Made correct 86% 77% decision’’
32% 48% 8% 0 12%
16% 52% 13% 19% 0
40% 21% 33% 50% 13% 29% 13% 0% [6.1–10]9 [6–10] 87%
*Data are given as %, or median [interquartile range].
76%
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Nissen 18 [14–29]; P 5 0.22). Lower esophageal sphincter residual relaxation pressure was, however, significantly higher after Nissen fundoplication (7 mm Hg [3–13] vs. 3 [0–5]; P 5 0.02). Late Reoperation A reoperative procedure was performed between 4 and 10 months after surgery in five patientsdtwo after anterior 90 fundoplication, and three after Nissen fundoplication. All of these procedures were undertaken and completed laparoscopically. The two reoperations in the anterior 90 fundoplication group were undertaken at 7 and 10 months postoperatively, and entailed conversion to a Nissen fundoplication for recurrent reflux. In the Nissen fundoplication group, all three reoperations were for dysphagia. They were performed at 4, 6, and 9 months after the original procedure. In two of these operations, the hiatus was tight and it was widened. In these patients, the fundoplication was thought to be loose, and therefore it was left intact. In the other operation, the hiatus was widened and the Nissen fundoplication was converted to a posterior partial fundoplication. DISCUSSION Controversy remains as to which fundoplication technique offers the best outcome for patients. Although uncontrolled studies have reported good results for Nissen, anterior partial, and posterior partial fundoplication variants,6,14,16 these studies should not be used to determine which technique is best. In recent years, there has been an increase in the number of prospective randomized trials that compare the short-term3,17,18 and long-term4,19 outcomes of various laparoscopic partial fundoplication techniques with the ‘‘gold-standard’’ Nissen 360 fundoplication. Hence, better evidence is becoming available that can help to determine the relative merits of the different types of laparoscopic fundoplication currently undertaken. We have evaluated progressive modifications to Nissen’s original procedure as part of a program to develop a fundoplication technique that achieves effective control of gastroesophageal reflux, but with minimal side effects and excellent patient acceptance. We have reported longer-term outcomes from a previous trial of anterior 180 partial fundoplication, which demonstrates that this approach achieves an excellent outcome compared with the Nissen procedure.4 Similar results have also been reported by Baigrie et al.20 Unfortunately, anterior 180 fundoplication is still followed by some side effects, and for this reason we developed the lesser anterior 90 fundoplication. Its
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antireflux efficacy has been demonstrated in previous laboratory and clinical studies. More recently, we reported the outcome from a larger multicenter randomized trial of Nissen fundoplication versus anterior 90 partial fundoplication7 and demonstrated the short-term efficacy of this procedure and its potential to significantly reduce the risk of side effects. We undertook the current prospective randomized trial independently of the recently reported multicenter study to further evaluate the anterior 90 technique in a single center against a Nissen procedure at which the short gastric vessels were not divided. Overall, the results from our new trial broadly concur with the findings from the multicenter study, that is, the anterior 90 technique is followed by fewer postoperative adverse effects. It could be argued that the increased wind-related problems associated with Nissen fundoplication might be attributable to division of short gastric vessels, and this step was integral to the design of the multicenter study protocol.8 Short gastric vessel division at Nissen fundoplication has previously been shown by our group, and others, to be associated with an increased risk of long-term wind-related problems without improving any outcome.8,10 In our current study, division of the short gastric vessels was not undertaken in any patients, suggesting that differences in wind-related symptoms in this trial are a function of the type of fundoplication, and not division of the short gastric vessels. In addition to any differences inherent in division of the short gastric vessels during Nissen fundoplication, the fact that our current study was undertaken at a single center also differentiates it from the previously reported multicenter study. The restriction of the current trial to a single unit, with all procedures undertaken or supervised by one of three surgeons, guaranteed the standardization of the technical aspects of the surgical procedures. This is particularly important when one is comparing a novel technique with a technique that is already established. It is possible that bias can be introduced in a multicenter setting, because surgeons in some of the centers may not be familiar with the newer of the techniques under scrutiny, leading to it being performed less well relative to the more conventional treatment. The fact that the results for the two trials are similar, however, also suggests that the anterior 90 fundoplication can be reliably performed by a wide range of surgeons. Our current trial, like all other trials including an anterior fundoplication variant, has demonstrated a lower incidence of postoperative dysphagia. Disparity in dysphagia profiles between the two procedures was evident from assessment at the end of the first postoperative month, continuing through
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to assessment at 1 year. Statistical significance was reached for most measures of dysphagia at 1 year. However, it should also be noted that the better adverse effect profile of the anterior 90 fundoplication group is, to some extent, counterbalanced by less effective control of reflux, and this is a similar outcome to the results from the other trial of anterior 90 fundoplication.7 Hence, there seems to be a trade-off between the risk of adverse effects and risk of recurrent reflux when comparing partial versus total fundoplication procedures. This premise is also strengthened by the indications for reoperation in the two groups in the present study. This outcome is also similar to that of other trials. A possible criticism of our current study is the asymmetrical distribution of operator level between the two groups, with a higher proportion of trainees undertaking the surgery in the Nissen group. Although this is a potential confounder, we have previously shown that outcome after laparoscopic fundoplication is not affected by the seniority of the principal operator.21 A further criticism could be the low rate of patients undergoing objective postoperative investigation with upper gastrointestinal endoscopy, 24-hour-pH monitoring, and esophageal manometry. However, overall satisfaction with the clinical outcome was similar after both types of fundoplication. In summary, our current study confirms that anterior 90 fundoplication is followed by fewer side effects than Nissen fundoplication. There is a trade off between this benefit and a greater likelihood of recurrent or incompletely controlled reflux, although overall satisfaction is at least as good after anterior 90 fundoplication. This outcome is similar to that reported in a previous trial, and it supports continued evaluation of anterior 90 fundoplication. However, longer-term follow-up is needed to determine the durability of this antireflux procedure.
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12.
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15. 16.
17.
The authors thank Nicky Ascott and Tanya Ellis for assistance with data collection and logistical support. 18. REFERENCES 1. Watson DI, Jamieson GG. Antireflux surgery in the laparoscopic era (review). Br J Surg 1998;85:1173–1184. 2. Watson DI. Laparoscopic treatment of gastro-oesophageal reflux disease. Best Pract Res Clin Gastroenterol 2004;18: 19–35. 3. Watson DI, Jamieson GG, Pike GK, Davies N, Richardson M, Devitt PG. A prospective randomised double blind trial between laparoscopic Nissen fundoplication and anterior partial fundoplication. Br J Surg 1999;86:123–130. 4. Ludemann R, Watson DI, Game PA, Devitt PG, Jamieson GG. Laparoscopic total versus anterior 180 degree
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21.
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fundoplication - five year follow-up of a prospective randomized trial. Br J Surg 2005;92:240–243. Yau P, Watson DI, Ascott N, Lafullarde T, Jamieson GG. Efficacy of a 90 degree anterior fundoplication versus a total fundoplication in an experimental model. Surg Endosc 2000; 14:830–833. Krysztopik RJ, Jamieson GG, Devitt PG, Watson DI. A further modification of the Nissen fundoplicationd90 degree anterior fundoplication. Surg Endosc 2002;16:1446–1451. Watson DI, Jamieson GG, Lally C, et al. Multicentre prospective double blind randomized trial of laparoscopic Nissen versus anterior 90 degree partial fundoplication. Arch Surg 2004;139:1160–1167. O’Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Division of short gastric vessels at laparoscopic Nissen fundoplicationdA prospective double blind randomized trial with five year follow-up. Ann Surg 2002;235:165–170. Watson DI, Pike GK, Baigrie RJ, et al. Prospective double blind randomised trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels. Ann Surg 1997;226:642–652. Luostarinen ME, Isolauri JO. Randomized trial to study the effect of fundic mobilization on long-term results of Nissen fundoplication. Br J Surg 1999;86:614–618. Luostarinen MES, Koskinen MO, Isolauri JO. Effect of fundal mobilisation in Nissen-Rossetti fundoplication on oesophageal transit and dysphagia. Eur J Surg 1996;162: 37–42. Blomqvist A, Dalenback J, Hagedorn C, Lonroth H, Hyltander A, Lundell L. Impact of complete gastric fundus mobilization on outcome after laparoscopic total fundoplication. J GASTROINTEST SURG 2000;4:493–500. Chrysos E, Tzortzinis A, Tsiaoussis J, Athanasakis E, Vassilakis JS, Xynos E. Prospective randomized trial comparing Nissen to Nissen-Rossetti technique for laparoscopic fundoplication. Am J Surg 2001;182:215–221. Jamieson GG, Watson DI, Britten-Jones R, Mitchell PC, Anvari M. Laparoscopic Nissen fundoplication. Ann Surg 1994;220:137–145. Dakkak M, Bennett JR. A new dysphagia score with objective validation. J Clin Gastroentrol 1992;14:99–100. Richardson WS, Trus TL, Thompson S, Hunter JG. Nissen and Toupet fundoplications effectively inhibit gastroesophageal reflux irrespective of natural anatomy and function. Surg Endosc 1997;11:261–263. Lundell L, Abrahamsson H, Ruth M, Sandberg N, Olbe LC. Lower esophageal sphincter characteristics and esophageal acid exposure after partial or 3600 fundoplication: Results of a prospective, randomized clinical study. World J Surg 1991;15:115–121. Laws HL, Clements RH, Swillies CM. A randomized, prospective comparison of the Nissen versus the Toupet fundoplication for gastroesophageal reflux disease. Ann Surg 1997; 225:647–654. Hagedorn C, Lonroth H, Rydberg L, Ruth M, Lundell L. Long-term efficacy of total (Nissen-Rossetti) and posterior partial (Toupet) fundoplication: Results of a randomized clinical trial. J GASTROINTEST SURG 2002;6:540–545. Baigrie RJ, Cullis SN, Ndhluni AJ, Cariem A. Randomized double-blind trial of laparoscopic Nissen fundoplication versus anterior partial fundoplication. Br J Surg 2005;92:819–823. O’Boyle CJ, Watson DI, deBeaux AC, Jamieson GG. Preoperative prediction of long-term outcome after laparoscopic fundoplication. ANZ J Surg 2002;72:471–475.
Although Nissen fundoplication is a very effective treatment for gastroesophageal reflux, it is associated with a small incidence of troublesome postoperative side effects. To prevent this, progressive modification of surgical techniques has led to the development of an anterior 90 fundoplication. We undertook a prospective randomized trial to compare this procedure with Nissen fundoplication to determine whether it would achieve a better clinical outcome. Patients presenting to a single center for primary laparoscopic antireflux surgery were randomized to undergo either an anterior 90 fundoplication (n 5 40) or a Nissen fundoplication without division of the short gastric vessels (n 5 39). Clinical questionnaires were used to assess outcome at 1 month, 3–6 months, and 12 months. Both patients and the clinical interviewer were masked as to which procedure was performed. Follow-up with endoscopy, esophageal manometry, and pH monitoring was also undertaken. Operating time was similar for the two procedures (60 minutes for anterior vs. 55 minutes for Nissen fundoplication). Early postoperative complications were more common after Nissen fundoplication (18% vs. 5%). Two patients underwent laparoscopic reoperation for recurrent reflux after anterior 90 fundoplication, and four underwent laparoscopic reoperation after Nissen fundoplication (dysphagia, 3 patients; acute hiatus hernia, 1 patient). One year after surgery, dysphagia and other wind-related side effects were less common after anterior 90 fundoplication. Control of reflux symptoms and satisfaction with the overall outcome was similar for the two procedures. Anterior 90 fundoplication is followed by fewer side effects than Nissen fundoplication. This advantage is offset by a greater likelihood of reflux recurrence. However, this does not diminish patient satisfaction. ( J GASTROINTEST SURG 2006;10:698–705) Ó 2006 The Society for Surgery of the Alimentary Tract KEY WORDS: Anterior partial fundoplication, dysphagia, gastroesophageal reflux, laparoscopy, Nissen fundoplication
Laparoscopic fundoplication has become the operative modality of choice for the surgical treatment of moderate to severe gastroesophageal reflux.1 The majority of laparoscopic fundoplications currently constructed are 360 fundal wraps, similar to the procedure originally described by Nissen. Despite achieving excellent control of reflux in the majority of patients, however, the 360 fundoplication can be followed by troublesome postoperative side effects. These include dysphagia and wind-related problems such as abdominal bloating, inability to belch, and flatulence.2
To overcome this, Nissen’s operation has been progressively modified. Undertaking a laparoscopic anterior partial fundoplication instead of a Nissen procedure has the potential to give good reflux control, but with less side effects. In 1999, we reported the early results of the first prospective randomized trial that compared the outcome of a Nissen fundoplication with an anterior 180 partial fundoplication.3 This study demonstrated that both procedures achieved satisfactory early control of reflux, but with less side effects after anterior 180 fundoplication. Longer term follow-up has since
From the University of Adelaide Department of Surgery, Royal Adelaide Hospital (G.M.S., G.G.J., C.J.L., P.G.D.), Adelaide, South Australia; and Flinders University Department of Surgery, Flinders Medical Centre (D.I.W.), Bedford Park, South Australia, Australia. Financial support for this study was provided from a project grant (no. 157986) from the National Heath and Medical Research Council of Australia (to D.I.W. and G.G.J.). Reprint requests: David I. Watson, M.D., F.R.C.S., Head, Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia. e-mail: [email protected] Ó 2006 The Society for Surgery of the Alimentary Tract
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1091-255X/06/$dsee front matter doi:10.1016/j.gassur.2005.10.003
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confirmed the durability of the anterior 180 fundoplication procedure beyond 5 years.4 Although side effects are less likely after anterior 180 fundoplication compared with Nissen fundoplication, a small risk of persistent dysphagia and wind-related problems remains. This led us to further refine the anterior fundoplication technique, resulting in the development of an anterior 90 fundoplication. Experimental and initial clinical studies have confirmed that anterior 90 fundoplication achieves good short-term reflux control, with a low risk of side effects.5,6 In addition, a multicenter prospective doubleblind randomized trial of laparoscopic Nissen fundoplication versus anterior 90 fundoplication has recently been published.7 This study was coordinated by our unit, and we contributed patients to it. The trial demonstrated that overall satisfaction with surgery was better 6 months after anterior 90 fundoplication, although this was offset to some extent by better reflux control in patients who underwent a Nissen fundoplication.7 In this recently reported study, the laparoscopic Nissen fundoplication procedures included division of the short gastric blood vessels. Four other randomized trials, including one from our unit, have shown that dividing these vessels is unnecessary during Nissen fundoplication,8–13 and two of these trials have demonstrated an association between division of the vessels and wind-related side effects.8,10 For this reason, we initiated another randomized trial of laparoscopic anterior 90 versus Nissen fundoplication, in which the short gastric vessels were not divided during Nissen fundoplication. This new trial is a single center experience with a different cohort of patients, rather than the combined experience of a larger group of surgeons. PATIENTS AND METHODS The protocol used for this study was similar to that used in other reported randomized trials undertaken by the authors and reported elsewhere.3,9 Participant Assignment Patients undergoing laparoscopic fundoplication for gastroesophageal reflux were randomly assigned to undergo either a total 360 (Nissen) fundoplication without division of the short gastric blood vessels or an anterior 90 partial fundoplication. Informed consent was obtained from all participants, and randomization was undertaken in the operating theater by opening one of 100 previously sealed opaque envelopes after surgery commenced.
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Patient Selection and Preoperative Investigation All patients with reflux who presented for laparoscopic antireflux surgery were considered for enrollment. Patients were excluded if they had a severe esophageal motility disorder that precluded the performance of a Nissen fundoplication, if they required a contemporaneous abdominal procedure (e.g., cholecystectomy), or had previously undergone any type of gastric surgery. All patients underwent preoperative investigation with esophageal manometry and endoscopy. Twenty-four-hour pH monitoring was performed to confirm reflux in patients who did not have unequivocal reflux disease demonstrated by endoscopy.
Operative Technique and Postoperative Care Laparoscopic Nissen fundoplication was performed using a technique described previously.14 This comprised preservation of the hepatic branch of the vagus nerve, routine posterior hiatal repair, and the construction of a short, loose Nissen fundoplication around a 52 Fr intraesophageal bougie. The short gastric vessels were not divided in any patients. The technique for anterior 90 fundoplication has also been described previously.6 The initial steps are similar to those undertaken for the Nissen proceduredmobilization of the esophagus, preservation of the hepatic branch of the vagus nerve, and posterior hiatal repair. The anterior 90 fundoplication was fashioned by first placing an esophagopexy suture between the posterolateral aspect of the right side of the distal esophagus and the posterior aspect of either the right pillar or both pillars of the esophageal hiatus. Two sutures were next placed between the left side of the esophagus and the adjacent gastric fundus to accentuate the angle of His, and the gastric fundus was then sutured loosely over the left side of the front of the esophagus by using an apical suture that anchored the fundus to the anterior esophagus and the apex of the hiatus. Finally, the inferior edge of the fundal fold lying in front of the esophagus was sutured to the esophagogastric junction in the midline. The short gastric vessels were not divided, and an intraesophageal bougie was not used. Patients were allowed oral fluids postoperatively on return to the ward, and soft solid food was commenced on the first postoperative day. Patients were instructed to remain on a soft diet for the first 3–4 weeks after surgery and then to gradually increase the consistency of their food intake thereafter.
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Masking
Table 2. Outcome assessment
The type of fundoplication performed was concealed from the patients during follow-up. Followup was undertaken by a research assistant who was masked to the randomization of each patient. Final data analysis for this paper was performed in late 2004 by a surgeon investigator (G.M.S) who was not involved in the original surgery.
Excellent Good Fair
Clinical Follow-up Preoperative and postoperative data were collected using a standard form. Follow-up data at 1 month, 3–6 months, and 1 year after surgery were obtained by telephone interview. Longer-term follow-up will be obtained in due course. The presence or absence of the following symptoms was sought: heartburn, epigastric pain, regurgitation, dysphagia for solids, dysphagia for liquids, odynophagia, early satiety, epigastric bloating, anorexia, nausea, vomiting, wheezing, coughing, and increased flatulence. The ability to relieve bloating and whether a normal diet was being consumed were also determined. Heartburn was also scored using a visual analogue scale (0 5 no heartburn, 10 5 severe heartburn). Dysphagia was scored by several methods. Visual analogue scales (0 5 no dysphagia, 10 5 total dysphagia) were applied separately for solids and liquids; a previously validated score (0 5 no dysphagia, 45 5 severe dysphagia) that combines information about difficulty swallowing nine types of liquids and solids was used as well.9,15 Overall outcome was determined using three further scales and a question. Patients were asked to assess the outcome of surgery by using a modified Visick grading (Table 1) and were asked to score the outcome as excellent, good, fair, or poor (Table 2). An overall assessment of satisfaction with the operative outcome was also determined using a further visual analogue scale (0 5 dissatisfied, 10 5 satisfied). In addition, patients were asked whether they thought that their initial decision to have a laparoscopic fundoplication was correct or not. The occurrence of any Table 1. Modified Visick grading system 1 2
3 4 5
No symptoms Mild symptoms easily controlled by simple care such as avoiding certain foods or eating small meals, etc. Moderate symptoms not controlled by simple care but not interfering with social or economic life Moderate symptoms interfering with social or economic life Symptoms as bad worse than preoperatively
Poor
Complete recovery Major improvement with minor problems Major improvement with still significant problems or adverse effects Minor or no improvement or deterioration
complications and the need for further surgery, whether early (within 6 weeks of the initial surgery) or late, was also recorded. Objective Follow-up Three to six months after surgery, patients were invited to undergo esophageal manometry, 24hour-ambulatory pH monitoring, and endoscopy. These investigations sought to obtain an objective assessment of lower esophageal sphincter function, postsurgical anatomy, and the degree to which reflux was controlled. Statistical Analysis The primary clinical outcomes that the trial was designed to evaluate were postoperative dysphagia and control of reflux symptoms. It was determined that 80 patients (40 in each group) would be needed to demonstrate a 15% difference in these outcome measures at a statistical significance level of P ! 0.05 and power of 80%. All analyses and comparisons between the two groups were performed on an intention-to-treat basis. Data were entered onto a computerized database (Filemaker Pro version 7, Filemaker Corporation, Santa Clara, CA) and analyzed with SPSS version 10 for Windows (SPSS Inc, Chicago, IL). Data are expressed as mean (standard error of the mean; mean [SEM]) or median (interquartile range; median [IQR]). Categorical variables were compared by using the Fisher exact test. Continuous variables that followed a parametric distribution were compared by using the independent samples t test. Nonparametric data were compared using the Mann-Whitney U test. Statistical significance was accepted if P ! 0.05. The protocol for this trial was approved by the Human Research Ethics Committee of the Royal Adelaide Hospital. RESULTS Seventy-nine patients who underwent a laparoscopic fundoplication between February 1999 and August 2003 at the Royal Adelaide Hospital were
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Laparoscopic Nissen vs. Anterior 90 Fundoplication
entered into this trial. Thirty-nine patients were randomized to undergo a Nissen fundoplication and 40 patients an anterior 90 partial fundoplication. Follow-up data was available for 71 (90%) patients at the 1-month follow-up point, 72 (91%) patients at 3–6 months follow-up, and 64 (81%) at 1 year follow-up. Missing data were due to the inability to contact patients at these specific follow-up points. Of the 15 patients who were not contacted at 1year postsurgery, 14 had 3–6 month follow-up data available, and 10 of these 14 patients had a good or excellent outcome at the point of last review. Data was available for 78 (99%) patients in at least one of the last two follow-up points. Preoperative Assessment Both study groups were well matched for preoperative parameters (Tables 3 and 4). The degree of heartburn experienced by each group and scored on a visual analogue scale was also comparable between both groups (Table 5), as was dysphagia (Table 6). Likewise, preoperative esophageal manometric parameters and endoscopic findings were similar for the two groups. Operation Operations were carried out under the care of three surgeons. Thirty-one procedures (39%) were performed by a consultant, and 48 (61%) were performed by a trainee under supervision. The seniority of the first operator was different for the two groups, there being a higher representation of trainees as the primary surgeon in the Nissen fundoplication group (74% vs. 48%; P 5 0.02). There was no deliberate Table 3. Preoperative patient characteristics Type of fundoplication Variable
Age, y Sex, M/F Height, cm Weight, kg Previous upper abdominal surgery Duration of symptoms (y)
Anterior (n 5 40)
Nissen (n 5 39)
46 (2) 24/16 171 (3) 84 (3) 6 (15%)
47 (2) 19/20 169 (2) 86 (3) 6 (15%)
0.62* 0.37‡ 0.51* 0.59* 0.99†
7 [4–12]
6 [3–20]
0.81‡
P value
Data are given as mean (standard error of mean), or median [interquartile range]. *Student’s t test. † Fisher exact test. ‡ Mann-Whitney U test.
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bias for this parameter, as randomization was always undertaken after commencing surgery. One patient who was randomized to undergo a Nissen fundoplication underwent an anterior 90 fundoplication, when the surgeon could not bring the gastric fundus behind the esophagus. This was due to the combined difficulties of excessive adipose tissue in the region of the cardia and a thickened gastric wall. The operating surgeon thought that this problem would not be solved by dividing the short gastric vessels, and hence, a partial fundoplication was performed. All other patients had a fundoplication constructed according to the randomization schedule. Outcomes were analyzed on an intentionto-treat basis. The laparoscopic procedure was converted to open surgery for one patient in the anterior 90 fundoplication group. This was because of intra-abdominal adhesions. All other procedures were completed laparoscopically. Operating times were similar for the two groups (median 60 minutes; interquartile range 45–75 minutes for anterior 90 fundoplication vs. median 55 minutes; interquartile range 40–65 minutes for Nissen fundoplication; P 5 0.18). Operating surgeons were asked to rate the degree of difficulty of the operative procedure by using a scale from 1 to 10. There was no difference in difficulty rating between the two groups (4 [3–7] for anterior 90 fundoplication vs. 4 [3–7] for Nissen fundoplication; P 5 0.92). Early Hospital Outcome The time interval between surgery and the commencement of oral fluids as well as the duration of postoperative hospital stay were not influenced by the type of fundoplication. Time to commencement of solids was longer in the Nissen fundoplication group (Table 7). The incidence of postoperative complications was higher in the Nissen fundoplication group (18% vs. 5%; P 5 0.09). However, most complications were minor and did not surgically require intervention, or delay discharge from the hospital. After anterior 90 fundoplication, there was one episode of chest infection and one episode of intraoperative cervical subcutaneous emphysema. After Nissen fundoplication, one patient developed urinary retention, one patient developed an umbilical port-site hernia, one patient suffered from excessive retching in the early postoperative period, which settled spontaneously, and three patients developed an intraoperative pneumothorax (none of which required any specific intervention). In addition, one patient in the Nissen group was found to have an acute paraesophageal hernia on a routine barium
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Table 4. Assessment of symptoms Postoperative Preoperative Symptom
Heartburn Epigastric pain Regurgitation Odynophagia Early satiety Epigastric bloating Anorexia Nausea Vomiting Cough Wheeze Can relieve bloat Eats normal diet Increased flatus
1 month
3–6 months
1 year
Anterior %
Nissen %
Anterior %
Nissen %
Anterior %
Nissen %
Anterior %
Nissen %
100 56 79 15 35 50 9 29 35 35 24 55 70 NA
97 71 89 24 53 61 16 50 34 34 26 53 70 NA
11 49 11* 20 60 37 26 23 3 20 9 38 47 54
14 39 39* 33 61 47 31 19 17 25 11 56 27 44
22 36 15 18 49 55 9 27 9 21 3 50 89 46
3 33 26 15 59 56 10 26 8 13 13 61 74 67
16 29 3* 7 26* 32 3 7* 7 26 0 69 90 42*
12 46 27* 18 67* 39 12 30* 6 15 0 50 83 79*
*P ! 0.05 (Nissen vs. anterior fundoplication, Fisher exact test).
swallow X-ray carried out on the day after surgery. This was repaired laparoscopically on the second postoperative day, and the patient then made an uneventful recovery. Clinical Outcome at 1 Month to 1 Year After Operation A detailed analysis of the clinical outcome at 1 month, 3–6 months, and 1 year are summarized in Tables 4, 5, 6, and 8. At 1 and 3–6 months, there were significant differences between the two groups for the symptoms of regurgitation at 1 month (less after anterior 90 fundoplication) and heartburn at 3–6 months (less after Nissen fundoplication). At 1 year, there were significant differences in the incidence of regurgitation, early satiety, nausea, and flatulence (all less after anterior 90 fundoplication). There was no significant difference between the Table 5. Assessment of heartburn by visual analogue scale Types of fundoplication
Preoperative Postoperative 1 month 3–6 months 1 year
Anterior
Nissen
P value
7 [2.8–9.1]
5 [3–8]
0.31
0 [0–0] 0 [0–0.5] 0 [0–2]
0 [0–0] 0 [0–0] 0 [0–0]
0.99 0.01* 0.08
Data are expressed as median [interquartile range]. *P ! 0.05 (Nissen vs. anterior fundoplication, Mann Whitney U test).
two groups for the assessment of heartburn by the yes/no question at 1 year (Table 4). With regard to the assessment of heartburn by using the visual analogue scale, the findings were similar to the findings determined by the yes/no question. A statistically significant difference was found in the heartburn scores at 3–6 months (less after Nissen fundoplication), but this was not found at 1 year (Table 5). With regard to the clinical assessment of dysphagia, there were significant differences between the two study groups, with less dysphagia experienced after anterior 90 fundoplication (Table 6). At 1 year, the incidence of dysphagia for solid foods, the visual analogue scores for dysphagia (for both liquids and solids), and the 0–45 dysphagia score all concurred. The satisfaction score, outcome profile, and modified Visick grading all failed to reveal a statistically significant advantage for either type of the fundoplication (Table 8). In both groups, most patients were satisfied with the outcome of their surgery. At both 3–6 months and 1 year postprocedure, more patients in the anterior 90 fundoplication group expressed the view that they had made the correct decision to undergo surgery (86% vs. 77% at 3–6 months, 87% vs. 76% at 1 year). However, these differences were not statistically significant (Table 8). Postoperative Investigations Patient compliance with scheduled objective postoperative investigations was low. Twenty-five (32%) patients underwent postoperative upper gastrointestinal endoscopy, 23 (29%) underwent 24-hour-pH
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12 [3.5–19.5]* 18*
Table 7. Early hospital outcomes Types of fundoplication Variable
0 [0–8.7]* 56*
Postoperative stay (days) Days to taking oral fluids Days to taking solid foods
24 [17.7–29.9]* 11 16 [0–25.5]* 27
Nissen
P value
2 [2–3] 1 [1–1] 1.5 [1–2]*
2 [2–3] 1 [1–1] 2 [1.5–2]*
0.42 0.52 0.03
monitoring, and 25 (32%) underwent esophageal manometry. Upper gastrointestinal endoscopy revealed an intact fundoplication and satisfactory repair of hiatus hernia in all patients studied. With regards to Savary-Miller grading of esophagitis, one of eight patients was scored as Savary-Miller grade 1 after anterior 90 fundoplication, and 1 of 16 patients had grade 3 esophagitis after Nissen fundoplication. Esophagitis was not present in any other patient. Twenty-four-hour pH monitoring demonstrated normalization of acid exposure times in all but one of the 23 patients studied. This patient had undergone a Nissen fundoplication. The percentage time with pH less than 4 over the 24-hour study period was significantly less in the Nissen fundoplication group (0% [0%–0.6%] vs. 0.7% [0.3%–2.5%]; P 5 0.02). The postoperative lower esophageal sphincter resting pressure measured at esophageal manometry was similar for the two groups (anterior 14 mmHg [10–24] vs.
9.5 [0–23.5]* 33*
5 [3.3–7.8]* 0 [0–4.3] 3 [0–6.8]* 0 [0–0]*
Anterior
Data expressed as median [interquartile range]. *P ! 0.05.
0 [0–12]* 66*
2 [0–6]* 0 [0–3]* 0 [0–2]* 0 [0–0]* 2.5 [0–6.3]* 0 [0–1]
13* 0 49 21* 30 0* 69 14 63 3
0 [0–2.5]* 0 [0–0]
49* 3
Nissen Nissen Anterior
Anterior
Nissen
Anterior
1 year 3–6 months 1 month
Postoperative
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Table 8. Postoperative Visick grading, outcome grading, and satisfaction scores
3–6 months *P ! 0.05. † Data are expressed as % or median [interquartile range].
8.2 [0–15.9] 44 1.7 [0–19.5] 50
0 [0–5] 0 [0–2.5] 0 [0–3.3] 0 [0–0]
21 8 32 6
Dysphagia for: Solids, % Liquids, % Visual Analogue Scale Solids Liquids Dysphagia score Overall result† Scored 0 only, %
Nissen Anterior Symptom
Preoperative
Table 6. Assessment of dysphagia
Postoperative status
Variable
1 year
Anterior Nissen Anterior Nissen
Modified Visick grade a 1 25% 21% 2 47% 54% 3 6% 3% 4 8% 18% 5 14% 5% Outcome Excellent 43% 28% Good 30% 41% Fair 11% 23% Poor 16% 8% Satisfaction 9 [7.5–10]9 [7–10]9 score* ‘‘Made correct 86% 77% decision’’
32% 48% 8% 0 12%
16% 52% 13% 19% 0
40% 21% 33% 50% 13% 29% 13% 0% [6.1–10]9 [6–10] 87%
*Data are given as %, or median [interquartile range].
76%
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Nissen 18 [14–29]; P 5 0.22). Lower esophageal sphincter residual relaxation pressure was, however, significantly higher after Nissen fundoplication (7 mm Hg [3–13] vs. 3 [0–5]; P 5 0.02). Late Reoperation A reoperative procedure was performed between 4 and 10 months after surgery in five patientsdtwo after anterior 90 fundoplication, and three after Nissen fundoplication. All of these procedures were undertaken and completed laparoscopically. The two reoperations in the anterior 90 fundoplication group were undertaken at 7 and 10 months postoperatively, and entailed conversion to a Nissen fundoplication for recurrent reflux. In the Nissen fundoplication group, all three reoperations were for dysphagia. They were performed at 4, 6, and 9 months after the original procedure. In two of these operations, the hiatus was tight and it was widened. In these patients, the fundoplication was thought to be loose, and therefore it was left intact. In the other operation, the hiatus was widened and the Nissen fundoplication was converted to a posterior partial fundoplication. DISCUSSION Controversy remains as to which fundoplication technique offers the best outcome for patients. Although uncontrolled studies have reported good results for Nissen, anterior partial, and posterior partial fundoplication variants,6,14,16 these studies should not be used to determine which technique is best. In recent years, there has been an increase in the number of prospective randomized trials that compare the short-term3,17,18 and long-term4,19 outcomes of various laparoscopic partial fundoplication techniques with the ‘‘gold-standard’’ Nissen 360 fundoplication. Hence, better evidence is becoming available that can help to determine the relative merits of the different types of laparoscopic fundoplication currently undertaken. We have evaluated progressive modifications to Nissen’s original procedure as part of a program to develop a fundoplication technique that achieves effective control of gastroesophageal reflux, but with minimal side effects and excellent patient acceptance. We have reported longer-term outcomes from a previous trial of anterior 180 partial fundoplication, which demonstrates that this approach achieves an excellent outcome compared with the Nissen procedure.4 Similar results have also been reported by Baigrie et al.20 Unfortunately, anterior 180 fundoplication is still followed by some side effects, and for this reason we developed the lesser anterior 90 fundoplication. Its
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antireflux efficacy has been demonstrated in previous laboratory and clinical studies. More recently, we reported the outcome from a larger multicenter randomized trial of Nissen fundoplication versus anterior 90 partial fundoplication7 and demonstrated the short-term efficacy of this procedure and its potential to significantly reduce the risk of side effects. We undertook the current prospective randomized trial independently of the recently reported multicenter study to further evaluate the anterior 90 technique in a single center against a Nissen procedure at which the short gastric vessels were not divided. Overall, the results from our new trial broadly concur with the findings from the multicenter study, that is, the anterior 90 technique is followed by fewer postoperative adverse effects. It could be argued that the increased wind-related problems associated with Nissen fundoplication might be attributable to division of short gastric vessels, and this step was integral to the design of the multicenter study protocol.8 Short gastric vessel division at Nissen fundoplication has previously been shown by our group, and others, to be associated with an increased risk of long-term wind-related problems without improving any outcome.8,10 In our current study, division of the short gastric vessels was not undertaken in any patients, suggesting that differences in wind-related symptoms in this trial are a function of the type of fundoplication, and not division of the short gastric vessels. In addition to any differences inherent in division of the short gastric vessels during Nissen fundoplication, the fact that our current study was undertaken at a single center also differentiates it from the previously reported multicenter study. The restriction of the current trial to a single unit, with all procedures undertaken or supervised by one of three surgeons, guaranteed the standardization of the technical aspects of the surgical procedures. This is particularly important when one is comparing a novel technique with a technique that is already established. It is possible that bias can be introduced in a multicenter setting, because surgeons in some of the centers may not be familiar with the newer of the techniques under scrutiny, leading to it being performed less well relative to the more conventional treatment. The fact that the results for the two trials are similar, however, also suggests that the anterior 90 fundoplication can be reliably performed by a wide range of surgeons. Our current trial, like all other trials including an anterior fundoplication variant, has demonstrated a lower incidence of postoperative dysphagia. Disparity in dysphagia profiles between the two procedures was evident from assessment at the end of the first postoperative month, continuing through
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to assessment at 1 year. Statistical significance was reached for most measures of dysphagia at 1 year. However, it should also be noted that the better adverse effect profile of the anterior 90 fundoplication group is, to some extent, counterbalanced by less effective control of reflux, and this is a similar outcome to the results from the other trial of anterior 90 fundoplication.7 Hence, there seems to be a trade-off between the risk of adverse effects and risk of recurrent reflux when comparing partial versus total fundoplication procedures. This premise is also strengthened by the indications for reoperation in the two groups in the present study. This outcome is also similar to that of other trials. A possible criticism of our current study is the asymmetrical distribution of operator level between the two groups, with a higher proportion of trainees undertaking the surgery in the Nissen group. Although this is a potential confounder, we have previously shown that outcome after laparoscopic fundoplication is not affected by the seniority of the principal operator.21 A further criticism could be the low rate of patients undergoing objective postoperative investigation with upper gastrointestinal endoscopy, 24-hour-pH monitoring, and esophageal manometry. However, overall satisfaction with the clinical outcome was similar after both types of fundoplication. In summary, our current study confirms that anterior 90 fundoplication is followed by fewer side effects than Nissen fundoplication. There is a trade off between this benefit and a greater likelihood of recurrent or incompletely controlled reflux, although overall satisfaction is at least as good after anterior 90 fundoplication. This outcome is similar to that reported in a previous trial, and it supports continued evaluation of anterior 90 fundoplication. However, longer-term follow-up is needed to determine the durability of this antireflux procedure.
Laparoscopic Nissen vs. Anterior 90 Fundoplication
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15. 16.
17.
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